Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical, Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dispensing Solutions, Inc.
Dispensing Solutions, Inc.
PSS World Medical, Inc.
066070785
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Details
NDC Product Code
66336-437Application Number
ANDA085762Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 17, 2012STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 1 1